Strategy & Organizational Development
- Support internal and external audits
- Own the training curriculum for their function profile
Maintenance & Calibration
Apply for permits related to maintenance / calibration / projectsPerform FMEA and define maintenance types per asset; assess equipment criticality (HML)Create / maintain / verify engineering documents (protocols, drawings, lists, schematics, diagrams, layouts, calculations, datasheets)Project Engineering & Control
Prepare cost estimations & conduct Value Improvement ReviewsPerform project risk assessmentsPrepare project initiation documents (Business Requirements – PBR, Work Breakdown Structure – WBS, Cost Breakdown Structure – CBS, Project Scope Statement – PSS)Develop project sourcing strategyIdentify technical solutionsDraft project quality planPrepare project procurement plan, manage tenders, and purchasingManage project HSE and conduct safety reviewsConduct project reviews (e.g., Technical Quality Review – TQR, constructability)Develop commissioning plan / strategySet up Project Change Management and handle changesSubmit legal permits for the projectPrepare equipment specifications and system requirements (e.g., User Requirements Specification)Develop project execution plan (e.g., construction phase)Prepare / execute project health & safety risk assessments (equipment / process)Prepare functional specificationsDraft, review, and approve drawings, lists, schedules, diagrams, layouts, calculations, and datasheetIssue orders / contracts based on technical specs and bill of quantitiesMonitor and manage project vendors / contractors / third partiesDevelop test specification / plans for commissioning & qualificationExecute construction management and installation supervisionPerform FAT / SAT / inspections of new equipmentImplement and monitor safety and inspection plans for contractorsExecute work orders according to procedural instructionsCarry out commissioning activitiesManage project deficiencies and deviationsDevelop and execute the project strategy based on customer needs (cost, schedule, functionality, qualityRe)Qualification
Develop qualification planPerform GMP risk assessments (incl. Sensor Risk Assessment – SRA)Create DQ, IQ, and OQ protocolsExecute DQ, IQ, and OQDraft DQ, IQ, and OQ reportsProvide technical troubleshooting during PQ and validationKey Performance Indicators (KPIs) : (How performance in this role is measured)
CAPEX projects delivered on time, within budget, and according to quality standardsProject reviews completed on time, with no critical observationsQualification plans approved and executed as planned, no major deviations, no overdue CAPAsNo critical findings during internal / external qualification auditsHighest safety standards applied during projects and operations; no critical findings in HSE audits, no LTI or SIFRole Aspects : (Key facts and figures)
Number of Subordinates :
Direct : Up to 20 external engineers in projectsIndirect : 0Functional :Financial ResponsibilitiesDirect impact on project budgets and expendituresOrganizational Impact :
Responsible for implementing technical solutionsAccountable for time, cost, and quality of discipline work during the projectEnsures technical project quality and best practicesHigh impact on availability, efficiency, and compliance of production facilitiesSignificant influence on lifecycle costs and COGSRequirements :
Relevant Experience :
5 years of technical experience, including 2 years in capital investment projects in the chemical or pharmaceutical industryLeadership experience managing external resourcesProven project management skills, including contract management and project controlBroad interdisciplinary knowledgeExtensive HSE and GxP / QA knowledgeEducation & Qualifications :
Degree in Engineering (Dipl. Ing. / M.Sc. / B.Sc.) or equivalentLanguages :
Fluent in English and proficient in the local language